TELEFLEX MEDICAL

LATEX MANUFACTURING PROCESS FLOW

1.

The latex quality requirement data for the Teleflex Medical Kamunting were sent to
Synthomer (M) Sdn. Bhd. to be compounded. The only compounding added before
the process in Teleflex is the colour for tagging different kind of rubber compound for
different application purpose. There are about 4-5 (red,blue,yellow,green,orange)
colours to tag the product to ease the product classification. The latex were
compounded in a constant temperature to prevent the crosslinking by heat to occur.
These latex were compounded and constantly stirred by a rotating blade at the bottom
of the latex tank. The stirring latex blade were placed at the bottom due to the
possibility of particle displacement. This is because latex contain water, thus the water
layer tends to stay on top while the heavy latex rubber particle will dispense at the
bottom. Hence we placed the rotating blade at the bottom to stir it well and thoroughly
to make an even latex compounding ready for the next process.

2.

In this process the sterilized catheter former were dipped in a coagulant and then
dipped in the latex tank. This layer is considered as the 1st layer and also as the
thinnest layer. This layer is the inner layer of the catheters. This dipped latex former
were stationed at the oven for a few minutes to make it not so sticky or rubbery or still
in the flow state to ease the next process.

3.

The dipped latex former with partial dryness were then taken out of the oven for the
threading process. This is the most important process and also the hardest process of
catheter manufacturing. In this process a thin high modulus rubber thread were
gummed inline or straight with the catheters former side. The threading will later be
removed after going through another process. These threading process is important as
it determines the tube size of the catheters.

4.

The threaded latex catheters were then dipped twice into the latex tank to cover the
threading and to make a hollow tube. After the dipping, the latex coated former was
stored in oven for a while not to fully

5.

After this, a very thin and small rubber tube were worn on the catheter end. It must
also cover threading. This is to provide an air flow to the small rubber tube to expand
once the thread is removed.

6.

Then all the catheter were dipped in a gum.

7.

Then again the same catheters were dipped in latex again for the reinforcement

purpose.

8.

The coding is where the catheters were coded by a code number, which determine the
date of processing of the latex catheters.

9.

Then the latex coated former of catheter were immersed in the latex tank for the last
time of latex dipping. Then it was stored in oven for certain period under average
temperature to precure the latex on the former.

10.

The Former was then taken out of the oven. The rubber thread were then removed
from within the coated layers of latex gently not to break the thread inside closing the
tube flow which can cause defects. Then with the help of a air pressure jet, the
catheters were totally removed from the former.

11.

The removed latex catheters were then punched at the end of the catheters for its
application purpose.

12.

Then the catheters were stored in a water bath of temperature 300c for almost 1 week
to displace any unwanted materials that could have deposited on the latex through the
whole process.

13.

Then they will undergo the process of chlorination. Water chlorination is the process
of adding chlorine (Cl. 2) or hypochlorite to water. This method is to kill certain
bacteria and other microbes in tap water as chlorine is highly toxic and they might
cause the rubber to decompose faster. Besides, it also provides a better looking
surface finishing for the catheters.

14.

After this the catheters were shelfed on a rack and placed in the big oven for a long
time for the complete curing of the catheters. This is the last chemically modifying
process in the manufacturing of catheters.

15.

Then the catheters were taken out of the oven and were inspected for any defects and
here the defected catheters were collected to the brought for furnace to be destroyed.
It cannot be recycled as the rubber is already fully cured.

16.

Then the balloon of the catheters were checked wheater it can expand and inflate back
to its normal size. The inflation of the balloon were aided with a little heat exposure.

17.

The Catheters were then ready for packing in the innerbag. With the help of the
vacuum pump the catheters were packed inside the bag.

18.

Then its automatically packed with the tiromat.

19.

This package then sent to Teleflex in Kulim for the sterilization process.

20.

Finnaly it is packed and ready for export and to be sent to any places that requires the
catheters.

LATEX MANUFACTURING PROCESS FLOW